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AVII77

01/29/20 8:25 AM

#261922 RE: Umibe5690 #261913

Les emphasised that big P are diametrically opposed to the new guidance. During the 60 day comment period comments supporting it need to be submitted in volume in order to drown out big P objections.


FWIW, the comment period was just extended an additional 30 days.

https://www.regulations.gov/docket?D=FDA-2019-D-4964

(assuming this is the guidance you are referring to. May not be as I don't know why BP would be "diametrically opposed" to it.)

Truthfan

01/29/20 9:03 AM

#261934 RE: Umibe5690 #261913

Indeed, shame, shame shame…..

Most innovative cancer drugs facing delays in reaching patients

“It is taking longer for new drugs to reach patients and, alarmingly, the delays are longest for the most exciting, innovative treatments, with the greatest potential to transform the lives of patients.”
Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London

https://www.firstwordpharma.com/node/1696886?tsid=28®ion_id=4